Label: FOOT HANGOVER- lidocaine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 31, 2018

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  • Drug Facts

  • Active ingredients (in each bottle)

    Lidocaine HCL 4%

  • Purpose

    External analgesic

  • Uses

    For the temporary relief of pain and itching due to minor burns, sunburn, minor cuts, abrasions, insect bites, and minor skin irritations.

  • Warnings

    For external use only. Avoid contact with eyes.

    Flammable: Do not use while smoking or near heat or flame.

    Do not use in large quantities, particularly over raw surfaces or blistered areas, on large areas of the body or on a cut, irritated or swollen skin, or for more than one week without consulting a physician.

    Stop use and ask a doctor if: conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets. If swallowed, get medical help or contact the Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day 
    children under 2 yearsask a doctor

  • Other Information

    Contents under pressure. Do not store at temperatures above 120° F

    When using this product; Use only as directed. Do not puncture or incinerate.

  • Inactive Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Distilled water), Parfum (Fragrance), Potassium Sorbate, Saccharide Isomerate, SD-Alcohol 40B

  • SPL UNCLASSIFIED SECTION

    Foot Hangover

    Los Angeles, California 90064

    (310)294-8956

  • Packaging

    FootHngover1

  • INGREDIENTS AND APPEARANCE
    FOOT HANGOVER 
    lidocaine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71436-0024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71436-0024-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2018
    Labeler - Ari Brands, Llc (080658382)
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